Medical device recalls Moderate risk

Raye's Inc. recalls SW Bari Lift & Transfer, Model Number 38060000

Recall date
January 25, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1595-2024
FDA classification
Class II
Brand / firm
Raye's Inc.
Sold / distributed
Worldwide distribution - US Nationwide and the countries of Australia, UK.

Why it was recalled

Retrospective engineering analysis against current ISO standards for hoists has determined: 1. The device cannot physically perform at maximum documented weight specifications when a factor of safety of two times the maximum load is applied. 2. The device is not equipped with a safety device to ensure a person with disability would not fall in the event of a single-fault condition of the lifting device.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

SW Bari Lift & Transfer, Model Number 38060000

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